Over 20 years of extensive experience in the medical devices industry including managing quality and regulatory affairs departments in both well-established and start-up companies.
In-depth experience with implementing quality management systems (QMS) in start-up companies, ISO 13485 and Quality System Regulation 21 CFR 820, Creating a Global Regulatory Affairs Strategy, Submit Technical File for CE certification, Submit application for TFDA in Taiwan, Submit application to Ministry of Health and Family Welfare (MHFW)-Government of India, Registering with AMAR the Israeli Ministry of Health鈥檚 medical device regulation unit, Creating Technical File for FDA 510k submission, Submit applicati...
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